41 Transobturator tape (TOT, TVT-O) An operation for stress incontinence Patient Information Women and Children - Obstetrics and Gynaecology
Transobturator tape Contents About this leaflet What is stress incontinence Alternatives to surgery The benefits of stress incontinence surgery General risks of surgery Specific risks of this surgery The operation: Trans-obturator tape (TOT or TVT-O) Facts and figures How is the operation performed After the operation British Society of Urogynaecology database Any questions write them here Things I need to know before I have my operation Describe your expectations from surgery An alternative operation, TVT Useful references About this leaflet We advise you to take your time to read this leaflet, any questions you have please write them down on the sheet provided (towards the back) and we can discuss them with you at our next meeting. It is your right to know about the operations being proposed, why they are being proposed, what alternatives there are and what the risks are. These should be covered in this leaflet. This leaflet firstly describes what stress incontinence is, it then goes on to describe what alternatives are available within our trust, the risks involved in surgery and finally what operation we can offer. What is stress incontinence? When women cough, sneeze, bend, jump or even laugh the pressure in the abdomen (tummy) is increased and this may result in leakage of urine - see figure 1 on following page - this is known as stress incontinence. This weakness is usually caused by childbirth in the first instance when the pelvic floor muscles and ligaments (attachments) are damaged. Further weakening occurs as one goes through the menopause because the quality of the supporting tissues deteriorates. The pressure in the abdomen rises when one coughs, sneezes or even bends, turns or jumps and results in urine leakage. This can cause a lot of distress and can limit one s quality of life. It must be understood that these operations will not cure all urinary symptoms. They will only cure urinary symptoms caused by a weakness in the urethra (urine pipe) and bladder neck. Many urinary symptoms we see in clinic have other causes. 2 3
Figure 1: Your anatomy - woman in upright position showing pressure above the bladder and a weak bladder neck. Bladder Area of weakness: bladder neck or mid urethra Pressure from cough, sneeze or movement Are there any alternatives to surgery? Uterus (womb) Vagina Rectum Urethra - tube between the bladder and outside Do nothing if the leakage is only very minimal and is not distressing then treatment is not necessarily needed. Pelvic floor exercises (PFE) - The pelvic floor muscle runs from the coccyx at the back to the pubic bone at the front and off to the sides. This muscle supports your pelvic organs (uterus and bladder) and your bowel. Any muscle in the body needs exercise to keep it strong so that it functions properly. This is more important if that muscle has been damaged. PFE can strengthen the pelvic floor and correct or reduce stress incontinence. PFE are best taught by an expert who is usually a physiotherapist. These exercises have little or no risk and even if surgery is required at a later date, they will help your overall chance of becoming continent. Devices - There are numerous devices (none on the NHS) which essentially aim to block the urethra. The devices are inserted either into the vagina or the urethra. They are not a cure but their aim is to keep you dry whilst in use, for example during keep fit etc. A leaflet is available if you require further information. What are the benefits of stress incontinence surgery? 80-90% women are substantially improved. This means you may get back to: physical activity running, dancing, gym, horse riding etc, gardening, resuming sexual relations if you have had to stop. We have been doing this operation for approximately seven to eight years (around 15 years for TVT) so long term data is not available, but the information we have so far suggests that the outcome following TOT is similar to TVT. This also means you may have renewed confidence so that:- You can e.g. go shopping etc without fear of leaking You do not have to worry about damp patches on clothing, in the car etc You do not have to worry about unpleasant odours. General risks of surgery Anaesthetic risk. This is very small unless you have specific medical problems. This will be discussed with you. 4 5
Haemorrhage. There is a risk of bleeding with any operation. The risk from blood loss is reduced by knowing your blood group beforehand and then having blood available to give you if needed. It is rare that we have to transfuse patients after their operation. Infection. There is a risk of infection at any of the wound sites. A significant infection is rare. The risk of infection is reduced by our policy of routinely giving antibiotics with major surgery. Deep vein thrombosis (DVT). This is a clot in the deep veins of the leg. The overall risk is at most four to five per cent although the majority of these are without symptoms. Occasionally this clot can migrate to the lungs which can be very serious and in rare circumstances it can be fatal (less than one per cent of those who get a clot). DVT can occur more often with major operations around the pelvis and the risk increases with obesity, gross varicose veins, infection, immobility and other medical problems. The risk is significantly reduced by using special stockings and injections to thin the blood (heparin). Specific risks of this surgery Failure: Ten per cent of women do not gain benefit from the operation. The operation however can be repeated. Voiding difficulty: Approximately ten per cent of women will have some difficulty in emptying their bladder in the short term and if this happens, we may send you home with a catheter for up to a week. If you still have difficulty emptying your bladder after ten days (three per cent), then the options will be either learning how to catheterise yourself (you may need to do that few times a day after passing urine to get rid of any urine left behind in your bladder), or going back to theatre to have the tape cut. Once the tape is cut, you may re-develop incontinence but there is an option of having another tape at a later date. Some women may need to change position to satisfactorily empty their bladder. Bladder over activity: Any operation around the bladder has the potential for making the bladder overactive leading to symptoms such as urgency (needing to rush to the toilet) and frequency (needing to visit the toilet more often than normal). Tape exposure and extrusion (ten per cent): The vaginal area over the tape may not heal properly or get infected and therefore part of the tape may need removing. This may need a return to theatre and may result in the operation being ineffective. Alternatively an attempt to re-cover the tape can be made. Very rarely the tape might erode into the urethra (urine pipe) or the bladder which would require an operation as well. The risk of exposure is increased by smoking and with certain diseases. Pain on intercourse: This may arise from scar tissue in the vagina as a result of the incision. It is unusual but unpredictable. Visceral trauma: During the sub-urethral sling operations the needle used may traumatise the bladder, or urethra (urine pipe). This is rare. If it is noticed after return from theatre to the ward it may necessitate going back to theatre for a general anaesthetic and an operation to repair the damaged organ. Leg or groin pain: occasionally some patients describe pain in the groin or down the legs. 6 7
The Operation: Trans-obturator tape (TOT or TVT-O) Facts and Figures. This is a recently developed operation and therefore less operations overall have been performed. The main advantage however is that the procedure now performed has less risk. The short-term results seem comparable to operations like the TVT, but the long-term results are unknown. The tape material used is similar to TVT. How is the operation performed? The operation can be performed under spinal or general anaesthetic. Special needles are used. The exit points for these needles are the groins see figure 2 and 3. There will therefore be a small incision in each groin as well as the incision in the vagina. These incisions will have a stich in after the operation. Figure 2: Insertion of Trans obturator tape (TOT) The helical needle is pushed through the groin incision and around the pubic bone into the vagina. The needle collects the tape which is pulled through the vagina to lie under the bladder neck. Figure 3: Insertion of Trans-obturator tape (TVT-O) Needle introducer Tape The needle is inserted from inside the vagina out through the groin carrying the tape with it. The same procedure is followed on the other side. The final position of the tape is under the urethra (tube between bladder and the outside). After the operation (post-operative care) After the operation you will be taken back to the ward, where the nurses will check your blood pressure, pulse and wound. You may eat and drink immediately on return from theatre. A mild painkiller may be required. Most women do not have a catheter and can go home once they have passed urine satisfactorily and been checked by a bladder scan that the bladder is empty on two occasions. Some women will return from theatre with a urethral catheter to drain the bladder. Once this is removed and they have emptied their bladder satisfactorily as above on two occasions they can go home. You may be given injections to keep your blood thin and reduce the risk of blood clots normally once a day until you go home or longer in some cases. 8 9
At home after the operation It is important to avoid straining particularly in the first weeks after surgery. Therefore, avoid heavy lifting and constipation. Avoiding constipation: Drink plenty of water / juice Eat fruit and green vegetables, especially broccoli Plenty of roughage e.g. bran / oats After any operation you will feel tired and it is important to rest. It is also important not to take to your bed. Mobilisation is very important. Simply pottering around the house will use your leg muscles and reduce the risk of clots in the back of the legs (DVT) which can be very dangerous. Activity will also help to get air into your lungs and reduce infections. You can do pelvic floor exercises but build these up very gently. If you do too much it will be uncomfortable. It is advisable to have showers rather than baths for three weeks and to keep puncture wounds clean and dry. They heal in about five days, dressings are given. Do not use tampons, have intercourse or swim for six weeks otherwise you put yourself at risk of the tape eroding into the vagina There are stitches in the skin wound in the vagina. The surface knots of the stitches may appear on your underwear or pads after about two weeks, this is quite normal. There may be little bleeding again after about two weeks when the surface knots fall off, this is nothing to worry about. There are also stitches in the groins. At two weeks gradually build up your level of activity. After four to six weeks, you should be able to return completely to your usual level of activity. You should be able to return to a light job after about three to four weeks. Leave a very heavy or busy job until six weeks. You can drive as soon as you can make an emergency stop without discomfort, generally after two weeks, but you must check this with your insurance company, as some of them insist that you should wait for six weeks. 10 11
Information about the British Society of Urogynaecology Surgical Database (Surgical Register) The British Society of Urogynaecology ( BSUG ) is a national group of gynaecologists with a special interest and expertise in the treatment of incontinence and prolapse. BSUG has developed a database of clinical and surgical data for the purposes of publishing anonymous statistical information for research purposes and to enable individual NHS Trusts and consultants to audit information about operations to ensure that the procedures performed at their hospitals are as safe and effective as possible. The patient information held in the BSUG database comprises name, hospital number and date of birth, together with clinical and surgical information ( patient identifiable data ). Because this information is confidential to each patient and is that patient s personal data within the meaning of the Data Protection Act 1998,we do not disclose patient identifiable data to BSUG without written consent. If you agree to allow us to enter your patient identifiable data into the BSUG database, please sign in the relevant section on the operation consent form. The benefits the BSUG database may bring to you: Improving patient awareness of the outcomes of incontinence and prolapse surgery. Finding out how long the different operative procedures last. Helping to identify individual patients who have received an implant and where there may be a need for urgent clinical review 12 The BSUG database will also be used to bring additional long-term benefits by: Providing feedback to gynaecological surgeons and teams to help maintain high clinical standards Promoting open publication about the performance of implants used in operations. Providing feedback on implant performance to regulatory authorities Providing feedback to suppliers about the performance of their implants Monitoring and comparing the performance of hospitals Data collection its security and confidentiality The BSUG database uses an electronic system for data collection. The data is sent securely to a protected database, avoiding the need to send paper records through the post, to ensure your data receives maximum protection. Your personal information is confidential and cannot be used outside of the BSUG database. Strict procedures are in place to protect your information and keep it confidential; it will only be available to you and your surgeon. If you wish, you can obtain access to a copy of your own record in accordance with the Data Protection Act 1998. 13
BSUG database Consent I consent to: 1. the processing of my patient identifiable data for the research and auditing purposes described in this information sheet. 2. the disclosure by BSUGs of my patient identifiable data to its IT service provider or any future IT service provider, where such IT service provider has: (a) agreed to adopt appropriate technical and organisation measures to protect the security of my patient identifiable data and only to process it in accordance with BSUGDL s instructions; (b) been instructed NOT to store my patient identifiable data on a server which is located outside of the United Kingdom; and (c) been informed of the existence of my legal right to confidence in respect of my patient identifiable data. 3. the disclosure of my patient identifiable data to the consultant team (and the NHS Trust employing that consultant team) who disclosed it to BSUG. 4. the disclosure of my patient identifiable data to BSUG or any legal entity which is wholly owned by BSUG, for processing in accordance with the consents in this section. Your participation is voluntary The form asks for your consent for your personal information to be recorded by the BSUG database. Your participation in the BSUG database is entirely voluntary. You can request access to view your entry on the BSUG database from your consultant team. If you agree and then change your mind, you may revoke this permission at any time by sending a written notice to your consultant OR to the address below. If you do not agree, your data will not be entered. BSUG Database Limited c/o BSUG, Royal College of Obstetricians & Gynaecologists 27 Sussex Place Regents Park London NW1 4RG If you consent to the above please sign in the relevant section on the operation consent form. 14 15
Things I need to know before I have my operation Please list below any questions you may have, having read this leaflet. 1.... 2.... 3.... 4.... 5.... 6.... Please describe what your expectations are from surgery. Alternative operations - please see leaflet 42: TVT An alternative operation to the TOT: The tension free vaginal tape. This operation involves inserting a synthetic tape through the vagina in order to sit like a hammock under the urethra (urine pipe) and prevent it moving down when the intra-abdominal pressure increases such as when coughing. It now has data to show that it gives comparable success rate to the above traditional operation (Colposuspension) up to 11 years after the operation, whilst allowing patients to go home on the same day in most cases. Its main drawback is a small risk of injury to bladder, urethra or bowels; and an extremely rare risk of damage to a major blood vessel which has resulted in a few deaths (out of greater than a million procedures). As with the TOT, there can be tape erosion and difficulty emptying the bladder and a small risk of overactive bladder symptoms (urgency and frequency). 1.... 2.... 3.... 4.... 5.... 6.... 16 17
Useful references You may find the address and websites useful to obtain more information. We can however bear no responsibility for the information they provide. Bladder & Bowel Foundation SATRA Innovation Park Rockingham Road Kettering, Northants, NN16 9JH Bladder & Bowel Foundation Nurse Helpline for medical advice: 0845 345 0165 Bladder & Bowel Foundation Counsellor Helpline: 0870 770 3246 Bladder & Bowel Foundation General enquiries: 01536 533255 Bladder & Bowel Foundation Fax: 01536 533240 mailto:info@bladderandbowelfoundation.org http://www.bladderandbowelfoundation.org Also: http://www.ics.org/documents/documents. aspx?documentid=2172 http://www.iuga.org/?patientinfo https://www.rcog.org.uk/en/patients/patient-leaflets/?q=&su bject=urogynaecology&orderby=title We hope that you have found this information helpful. Please remember our staff will be happy to answer any questions you have about any aspect of your care and welcome any comments about this leaflet. The James Cook University Hospital Appointments Desk: 01642 854861 / 282714 / 854883 Gynaecology Outpatients Dept. (Including Pre-admission Service): 01642 854243 Surgical Admissions Unit: 01642 854603 Gynaecology Unit / Theatre 23: 01642 282745 Women s Health Unit / Ward 19: 01642 854519 The Friarage Hospital Appointments Desk: 01609 764814 Gynaecology Outpatients Dept: 01609 764814 Pre-admission Service: 01609 764845 / 01609 763769 Surgical Admissions Unit Reception: 01609 764847 Nursing Staff: 01609 764657 From 7am Mondays until 5pm Fridays, Allen POS.D.U.: 01609 764405 From 5pm Fridays until 7am Mondays, Allerton Ward: 01609 764404 18 19
Comments, compliments, concerns or complaints South Tees Hospitals NHS Foundation Trust is concerned about the quality of care you receive and strives to maintain high standards of health care. However we do appreciate that there may be an occasion where you, or your family, feel dissatisfied with the standard of service you receive. Please do not hesitate to tell us about your concerns as this helps us to learn from your experience and to improve services for future patients. Patient Advice and Liaison Service (PALS) This service aims to advise and support patients, families and carers and help sort out problems quickly on your behalf. This service is available, and based, at The James Cook University Hospital but also covers the Friarage Hospital in Northallerton, our community hospitals and community health services. Please ask a member of staff for further information. Acknowledgement: Images courtesy of Americal Medical Systems, Inc and Ethicon Author: Urogynaecology team, department of obstetrics and gynaecology The James Cook University Hospital Marton Road, Middlesbrough, TS4 3BW. Tel: 01642 850850 Version 1, Issue Date: November 2014, Revision Date: August 2016 MICB4645